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7:30 am Registration and Morning Coffee
8:15 Chairperson’s Welcome and Opening Remarks
8:30 Identifying Training Issues through Review of Recent 483s and Warning Letters
Dr. Paul Papagni, Executive Director, Office of Vice President for Clinical Research, M.D. Anderson Cancer Center
The FDA has changed their focus from simply addressing egregious events to a more protocol-focused approach. 483s and warning letters recognize protocol deviations as a serious concern from both a safety and data integrity perspective. This session will use the 483s and warning letters as instructional tools to emphasize protocol adherence and also the importance of a well-written and designed study protocol. The audience will understand the current trends and focus of FDA enforcement actions. Further, they will understand how to incorporate 483 and warning letter findings into their training and monitoring activities.
9:15 Proactive Training to Avoid Non-Compliance: Lessons Learned from FDA Inspections
Lorrie D. Divers, Director, Clinical Trials Quality Assurance, ACM Global Central Laboratory
Training should be an ongoing effort, not a one-time event. By applying Quality System principles and proactively addressing issues as early as possible in the course of a clinical trial, focused training and reference tools can effectively prevent FDA warning letters and inspection observations. Your speaker will demonstrate:
- How initial training should be followed up with assessments of effectiveness through monitoring and auditing
- How to develop training focused on the root cause of issues to avoid further or more severe non-compliance
- Examples of lack of training cited by FDA inspectors
- How focusing on quality from the start and building it into processes will produce compliance
10:00 Networking Coffee Break and Exhibit Viewing
10:30 Got Content; Now What? Developing and Evaluating Content for Core Competency Training and Optimal Learning
Shawn Andrews, M.B.A., Training Manager, Global Medical Affairs, Allergan
Customizing training to meet the needs of various groups within your organization can be a daunting task. Furthermore, designing training curriculums to enhance core competencies can be an additional challenge. In clinical training organizations, most of us have no shortage of slide decks, studies, and other clinical resources, but how do we package these resources to meet the needs of our audience and maximize their learning? How do we ensure that we are training to their core competencies? In this workshop, we will discuss how to turn the clinical resources into formal, customized curriculums designed with instructional design and adult learning principles in mind. We will explore ways to utilize a Learning Management System in order to maximize use of resources. We will also discuss how to continually enhance the quality of your content while integrating different types of resources to keep your learners engaged.
- Learn how to develop formal, customized training curriculums to meet the needs of your audience and train to core competencies
- Learn how to turn your current content into polished training resources by applying instructional design and adult learning principles
- Explore ways to utilize a Learning Management System in order to maximize use of resources
- Learn how to continually enhance the quality of your content while integrating different types of resources to keep your learners engaged
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11:30 Strategies for Developing Proactive Training Initiatives in the Current Regulatory Environment
In today’s environment, training departments must take a proactive approach to designing comprehensive training programs that serve to minimize the potential for regulatory citations. During this interactive facilitated session, participants will be given the opportunity to participate in discussions about what has worked, what has not, and how to move away from making training initiatives a “box checking” exercise. Core topics to be covered include:
- Program design considerations
- Addressing current inspection trends in your training initiatives
- Strategies for achieving senior level buy-in
- And more!
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12:15 pm Sponsored Luncheon or Lunch on Your Own
1:30 Establishing a Clinical Research and GCP Training Program for Clinical Investigators and their Staff at Boston University/Boston Medical Center: The Experience of One Academic Institution
Sylvia Baedorf Kassis, M.P.H., Regulatory Education Manager, Clinical Research Resources Office, Boston University/Boston Medical Center
In order to establish a clinical research and GCP training program at an academic institution, several factors need to be considered, including executive level support, marketing of services, networking with departments and individual clinical investigators to make the “sell,” and of course, hiring staff with an expertise in clinical research and regulations. This session will focus on the process of implementing a training program at Boston University/Boston Medical Center for all levels of the research team with an emphasis on how to establish adequate processes and training for compliance with the regulatory requirements and guidances governing clinical research and protection of human subjects.
- Discuss challenges and best practices in academic-based clinical research and GCP training programs
- Recognize challenges in establishing a clinical research and GCP training program and develop strategies to overcome them
- Apply lessons learned at BU/BMC to the development or enhancement of their own clinical research training programs
2:00 Going Back to the Basics to Ensure Continued Success in the Future: Bayer’s “Back to the Future” Monitor Training Program
Janice Mas, Global Clinical Operations Training Manager, Bayer HealthCare Pharmaceuticals, Inc.
The first priority for Bayer as we bring drugs through development to a successful submission is patient safety. This can only be achieved by ensuring that the level of compliance to GCP meets the high standards of all regulatory agencies, as well as the internal standards of Bayer HealthCare. Going back to the basics to strengthen the monitor’s understanding of the foundational principles of the clinical trial process serves to reinforce their proficiency as proactive Site Managers. This presentation provides an overview of the program’s concept, design, and implementation focusing on:
- The key considerations in the program’s design and delivery
- The structural details of the “Back to the Future” program
- Lessons learned
2:45 Networking Refreshment Break and Exhibit Viewing
3:05 Regulatory and Protocol Specific Training for IND Studies in the Academic Setting: Opportunities and Challenges
Chicquita Hatten, Director, IND Office, Office of the Vice President for Clinical Research, The University of Texas M.D. Anderson Cancer Center
At the University of Texas M.D. Anderson Cancer Center, the institution sponsors the IND for investigator-initiated trials, taking on the role of Sponsor on behalf of the investigator. This centralized approached allows for regulatory training for the investigator and staff via the start-up meeting, and through continued communications with the Monitor and Project Manager throughout the life of the trial. However, the investigator is often the most knowledgeable about the agent/device being tested. Providing and documenting training regarding the agent can be additionally challenging if it is a novel agent developed and being studied at the institution. The Sponsor, via the monitor, while not specifically responsible for providing all required training, does have a responsibility to review training information for sub-investigators and research staff. This presentation will explore the opportunities for training in the academic setting and also some of the challenges and potential strategies for providing comprehensive training for investigator-initiated IND trials.
- Understand the importance of protocol specific training and documentation of training for investigators, research team members, and particularly sub-investigators participating in investigator-initiated clinical trials
- Know the challenges of ensuring appropriate protocol specific education in the academic setting when the sponsor is an individual or an institution
- Hear potential strategies for providing protocol specific training, both regulatory and intervention (agent/device) specific
- Understand the compliance and FDA enforcement considerations for failure to provide instruction to participating investigators and sub-investigators
3:50 Strategies for Maximizing Training Resources in Small- to Mid-Sized Companies
Pranob Bhattacharya, Associate Director, Drug Development Project Management, Astellas Pharma Global Development, Inc.
With the emergence of industry-wide cost-saving measures, the importance of maximizing resources including training is pivotal to ensuring effective team performance and successful execution. This talk will address three key areas by which training resources in small/medium companies can be maximized: 1. Creating and Optimizing Trainings; 2. Training Logistics and Engaging Learners; 3. Maximizing ROI from Trainings. During this session, participants will:
- Gain an understanding of different training logistics, including technology in use for global teams
- Proactively assess team needs to optimize training potential
- Learn strategies for utilizing training gaps in relation to upcoming activities/milestones
- Utilize solid training techniques that enable maximizing the resources at
one’s disposal
- Understand the importance of overcoming shortages in hard-resources by using effective, need-based training
- Learn creative ways to measure impact and content retention/execution until the next training session
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4:35 Facilitated Roundtable Session (choose one)
A) Strategies for Training Global and Remote Teams
B) Designing Engaging Clinical Research Training Programs
C) Using Technology in Training Initiatives: Proven Strategies from the Field
D) Maximizing Training Resources in Small to Mid-Sized Companies
E) Employing Social Media in Training Initiatives: Twitter, Podcasts, Wikipedia, Social Networks, and YouTube
F) Turning “Subject Matter Experts” into Best-in-Class Trainers&
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5:20 Wrap-Up and Close of Day One
5:30-6:30 Reception and Exhibit Viewing
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